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Global Medical Affairs Leader, Early Myeloma Assets
Raritan, New Jersey
Requisition ID: 6302171211
Janssen Global Services, L.L.C., a member of Johnson and Johnson's Family of Companies, is seeking a Global Medical Affairs Leader, Early Myeloma Assets based in Raritan, NJ with up to 30% domestic and international travel.
Janssen Global Services, L.L.C, encompasses groups that provide leadership across critical business areas for Janssen Pharmaceuticals including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; Pharmaceuticals Group Business Development and others.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Bring your talents to our mission, visit http://www.janssenrnd.com/ and www.JanssenPharmaceuticalsInc.com to learn more.
The Global Medical Affairs Leader, Early Myeloma Assets will be responsible for leading the clinical-commercial optimization for early myeloma product development and life cycle management strategies and plans. Partner closely with the Myeloma Strategy Leader, Oncology GMA Operations Leader, Regional Medical TA/Product Leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
The early myeloma Global Medical, Affairs Leader will be an integral member of the late stage development Compound Development Teams for early myeloma assets. In addition, will participate on the Global Commercial Team and as an ad hoc member of the clinical team. The early asset Global Medical, Affairs Leader will also be a core member of the early asset SMTs. The early asset Global Medical, Affairs Leader will be responsible for the development of global medical affairs plans that reflects prioritized regional needs, which are included in the overall Compound Development Plan.
In addition, the Global Medical, Affairs Leader will be accountable for the leading the global publication plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives. The Global Medical, Affairs Leader will also be responsible for facilitating and ensuring a consistent approach to global late stage Medical Affairs programs/activities globally.
• Develop global medical affairs strategy and plan for the compound based on prioritized regional needs. In addition, partner closely with the Vice President of Global Medical Affairs, Myeloma Strategy Leader and other GMALs to ensure one franchise strategy.
• Work with the CDTs to ensure integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs.
• Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from Phase IIa through Phase IV. Responsible for pre-launch medical activities including product/ Therapeutic Area global advisory boards, medical symposia and congress activities, in collaboration with functional leads of regional activity in these areas.
• Will be an active member of the core product CDTs and will lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one "unified" voice on the CDT.
• Collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions.
• Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars.
• Lead global publications planning process oversight (with vendor support) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development.
• Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences (e.g. Symposia).
• Responsible for review and approval of proposed evidence generation activities within Medical Affairs for oncology products. Responsible to ensure all global activities follow J&J Compliance principles, e.g. Health Care Compliance, etc.
• A minimum of an Advanced degree (MD, PhD or PharmD) is required.
• Experience in Myeloma is strongly preferred.
• Five or more years of combined relevant experience in Medical Affairs, Clinical, Scientific and/or Pharmaceutical environments is preferred.
• A demonstrated track record leading highly matrixed, cross/multi-functional work teams comprised of high-level managers and executives is required.
• Direct experience in multiple markets, ability to partner cross culturally/regionally is preferred.
• In-depth knowledge of study methodology, data reviews and analysis is preferred.
• Excellent knowledge of study execution, benefit risk management and lifecycle management is required.
• Highly innovative to drive a complex and changing environment and effectively manage and resolve issues within the therapeutic area is required.
• Good scientific knowledge, ability to hold peer-to-peer discussions with key external partners is required.
United States-New Jersey-Raritan
Janssen Global Services, LLC (6085)